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Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

Primary Purpose

Coronary Artery Disease (CAD)

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Custodiol-N

Custodiol

About this trial

This is an interventional treatment trial for Coronary Artery Disease (CAD) focused on measuring CAD, ACVB

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery.

Patients >/=35 and </=80 years of age
Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation
Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction.
Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis.
Eligibility for Swan-Ganz-Catheter
Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
No evidence of severe organic or psychiatric disease by history or physical examination
No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment.

Exclusion Criteria:

Patients undergoing valve repair or replacement
History of recent (< 6 weeks) Q-wave myocardial infarction
Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
Pregnant or lactating patients
Patients who have participated in any other investigational studies within 30 days previous to enrollment
Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
Patients with severe chronic obstructive lung disease (FEV1 < 50%)
Previous cardiac valvular disease (clinical relevant)
Dialysis or creatinine > 2 mmol/L
BMS-Stent < 4 weeks
DES-Stent < 6 month
Guidance depended Plavix therapy

Sites / Locations

Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Herzzentrum Leipzig GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Custodiol

Custodiol-N

Arm Description

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

Outcomes

Primary Outcome Measures

CK-MB area under the curve within 24 hours

Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp

Secondary Outcome Measures

Catecholamine requirement

Catecholamine requirement on surgical ICU within 24 hours

CK-MB peak

CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp

Mortality any time during post-op through Day 30

Mortality will be documented at any time during post-op through Day 30

Full Information

NCT ID

NCT01444235

First Posted

September 29, 2011

Last Updated

May 16, 2013

Sponsor

Dr. F. Köhler Chemie GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01444235

Brief Title

Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

Official Title

A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. F. Köhler Chemie GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.

Detailed Description

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease (CAD)

Keywords

CAD, ACVB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Custodiol

Arm Type

Active Comparator

Arm Description

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

Arm Title

Custodiol-N

Arm Type

Experimental

Arm Description

After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.

Intervention Type

Drug

Intervention Name(s)

Custodiol-N

Intervention Description

Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes

Intervention Type

Drug

Intervention Name(s)

Custodiol

Intervention Description

Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Primary Outcome Measure Information:

Title

CK-MB area under the curve within 24 hours

Description

Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp

Time Frame

Up to 24 hours after the aortic clamp release

Secondary Outcome Measure Information:

Title

Catecholamine requirement

Description

Catecholamine requirement on surgical ICU within 24 hours

Time Frame

24 hours (cumulative dose)

Title

CK-MB peak

Description

CK-MB peak on the days 2, 3, 4 and 5 after removal of aortic cross clamp

Time Frame

Up to day 5

Title

Mortality any time during post-op through Day 30

Description

Mortality will be documented at any time during post-op through Day 30

Time Frame

Up to Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery. Patients >/=35 and </=80 years of age Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction. Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis. Eligibility for Swan-Ganz-Catheter Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study No evidence of severe organic or psychiatric disease by history or physical examination No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment. Exclusion Criteria: Patients undergoing valve repair or replacement History of recent (< 6 weeks) Q-wave myocardial infarction Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO) Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery Pregnant or lactating patients Patients who have participated in any other investigational studies within 30 days previous to enrollment Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support) Patients with severe chronic obstructive lung disease (FEV1 < 50%) Previous cardiac valvular disease (clinical relevant) Dialysis or creatinine > 2 mmol/L BMS-Stent < 4 weeks DES-Stent < 6 month Guidance depended Plavix therapy

Overall Study Officials: